# A Solid-Phase, Long-Acting CCR5 Monoclonal Antibody for HIV Transmission

> **NIH NIH R01** · OREGON HEALTH & SCIENCE UNIVERSITY · 2022 · $945,533

## Abstract

PROJECT SUMMARY
With 36 million people currently living with HIV worldwide and no vaccine currently available, developing a pre-
exposure prophylactic (PREP) HIV regimen that protects against sexual transmission remains a top global health
priority. Recently, a CCR5 blocking monoclonal antibody, Leronlimab, has shown exceptional safety, tolerability,
and anti-HIV activity in multiple clinical trials. Given that sexual transmission of HIV is almost exclusively
mediated by CCR5-tropic variants, Leronlimab may be extremely effective as a PREP reagent. We confirmed
the ability of once-weekly administered Leronlimab to protect macaques from rectal transmission of CCR5-tropic
SHIV. However, a once-quarterly at home formulation would dramatically increase patient adherence. To this
end we will develop a novel formulation of long-acting Leronlimab that can be administered at home in a low
volume able to provide coverage for three months. In specific aim 1, we will determine the pK and receptor
occupancy of this new Leronlimab formulation in blood and tissue sites of sexual transmission. In specific aim 2,
we will determine the length of time a single injection at the clinical dose can protect both male and female
macaques against rectal transmission. In specific aim 3, we will determine the length of time a single injection of
the clinical dose can protect against vaginal transmission in cycling female macaques. These studies will
determine the optimal clinical dosing of long-acting Leronlimab and lay the foundation for testing long-acting
Leronlimab clinically as PREP in individuals at high-risk of acquiring HIV via sexual transmission.

## Key facts

- **NIH application ID:** 10443716
- **Project number:** 5R01AI154559-03
- **Recipient organization:** OREGON HEALTH & SCIENCE UNIVERSITY
- **Principal Investigator:** Jonah B. Sacha
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $945,533
- **Award type:** 5
- **Project period:** 2020-07-23 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10443716

## Citation

> US National Institutes of Health, RePORTER application 10443716, A Solid-Phase, Long-Acting CCR5 Monoclonal Antibody for HIV Transmission (5R01AI154559-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10443716. Licensed CC0.

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